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Sign Fracture Care International

FDA Regulatory Profile

Sign Fracture Care International has 0 FDA recalls, 2 inspections, 4 510(k) clearances and 1 compliance action on record.

Latest inspection
Aug 10, 2017 · NAI
Latest 510(k)
Jul 20, 2017

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances4Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 10, 2017Richland, WADevicesNo Action Indicated (NAI)3003356728
Nov 30, 2011Richland, WADevicesNo Action Indicated (NAI)3003356728

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K163589SIGN IM NailJul 20, 2017
K153759SIGN Compression Screw SystemFeb 25, 2016
K152757SIGN Hip Construct (SHC)Nov 13, 2015
K122823SIGN PEDIATRIC FIN NAILApr 16, 2013

FDA data resources